Tinted lenses and methods of manufacture

ABSTRACT

The present invention recognizes that lenses, such as contact lenses, can be pigmented using ink that include polymers or polymerizable monomers, preferably the same monomers used to make the lens. The ink can be used to make images on or within the lens. Images made using these inks are preferably digital and can be used in a variety of printing methods, including ink-jet printing.

The present application claims benefit of priority to U.S. provisionalpatent application Ser. No. 60/162,695 to Doshi, filed Nov. 1, 1999,U.S. provisional patent application Ser. No. 60/218,710 to Doshi, filedJul. 17, 20001, this application is a DIV of U.S. patent applicationSer. No. 09/696,933 to Doshi, filed Oct. 25, 2000 and PCT applicationnumber PCT/US00/41454 filed Oct. 23, 2000, each of which is incorporatedherein by reference.

TECHNICAL FIELD

The present invention generally relates generally to the fields oftinted lenses and methods of manufacture.

BACKGROUND

Tinted contact lenses have steadily gained in popularity since theirintroduction into the marketplace. In particular, colored contact lensesthat include images that mimic the iris of an eye are particularlypopular. However, colored contact lenses made by traditionaltechnologies suffer from poor image quality and other difficulties,including leaching of pigments present on the surface of lenses,unnatural appearances, fading of colors and limited number of colors tochoose from. The present invention addresses these problems, andprovides additional and related benefits as well.

A variety of colored contact lenses and methods of making them have beendescribed. For example, U.S. Pat. No. 5,018,849 to Su et al., issued May28, 1991, describes colored contact lenses that form a laminatedstructure whereby a pigment is provided on the top layer of the contactlens and opaque material is sandwiched between two layers of the contactlens material, such as polymers. The opaque material blocks the naturalcolor of the wearer's iris, and the pigment gives the wearer's eye theappearance of a desired color. These contact lenses have the undesirablequality of looking unnatural due to the limited number of colors thatare available. In addition, during manufacture the opaque material andpigment are applied to the contact lens material in a plurality ofsteps, using one color per step.

In U.S. Pat. No. 5,034,166 to Rawlings et al., issued Jul. 23, 1991,non-laminated colored contact lenses are described. The pigment in thistype of colored contact lens is casted into the structure of the lensmaterial. The pigment is dispensed one color at a time during lensmanufacturing which limits the number of colors that can be used to makecolored contact lenses. The resulting colored contact lens isundesirable because the wearer's eyes appear unnatural. Furthermore, thepattern and pigments used in this method is limited which results in anunnatural looking contact lens. Also, existing methods provide customerswith limited choices of colors and patters and the lenses produced bythese methods can provide pigments on the a surface of a lens, which canmake the lenses uncomfortable for the wearer and prone to fading of thepigment.

The colored contact lenses described in U.S. Pat. No. 5,106,182 toBriggs et al., issued Apr. 21, 1992, described a laminated coloredcontact lens. In this contact lens, pigmentation is provided on oneportion of a contact lens using a pad transfer method using a rubberstamp having raised radial segments. The pad transfer method appliespigment to the portion of the contact lens to form a crude pattern. Thepad is then pressed to the portion of the contact lens to smear thepigment and the pad disengaged from the portion of a contact lens. Thelens is rotated, and the process is repeated as desired. The resultingcolored contact lens is undesirable because of the limited number ofcolors that can be used and the resulting pigmentation pattern has anunpredictable and unnatural appearance.

U.S. Pat. No. 5,160,463 to Evans et al., issued Nov. 3, 1992, describesa colored contact lens made by applying a first pigment in a firstpattern to a molding device. Additional pigments in additional patternscan be applied to the molding device in independent applications. Theresulting image on the molding device can be transferred to a contactlens. The use of multiple printing steps is undesirable due to theincreased number of applications that are needed to create an image. Inaddition, this method results in an image of unnatural appearance due tothe limited number of colors that can be used to create the image.

Colored contact lenses reported in U.S. Pat. No. 5,414,477 to Jahnke,issued May 9, 1995, relate to images that are made using pad transfermethods to form a plurality of dots of unnatural appearance. A pluralityof printing processed can be used to create an image comprising morethan one color that reportedly results in an image with a more naturalappearance. These dots are of relatively definite in shape andrelatively large in size and thus have an unnatural appearance. Thecolored contact lenses made using these methods also have a limitednumber of colors and patterns that can be used, which results in anunnatural looking product.

The present invention addresses the problems associated with describedtinted contact lenses by providing an image on or within a contact lensthat is of superior quality. The increased quality of the image resultsin a tinted contact lens that has a natural appearance.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 depicts a schematic diagram of a method of printing digitallyencoded images. A1 denotes black ink; A2 denotes magenta ink; A3 denotesyellow ink; A4 denotes cyan ink; A6 denotes color ink coat/layer ofA1+A2+A3+A4. The digitally encoded image is printed on a surface such asa lens.

FIG. 2 depicts diagram of laminate digitally encoded images encasedwithin a structure. A6 denotes color ink coat/layer of black, magenta,yellow and cyan; A7 denotes partially polymerized monomer mix for clearlens; A8 denotes partially polymerized A6; A9 denotes fully polymerizedclear lens.

FIG. 3A depicts a method of encasing a layer of ink between a primarysurface and a polymer layer. A5 denotes a monomer mix for clear lens; A6denotes color ink coat/layer of black, magenta, yellow and cyan; A7denotes partially polymerized A5; A8 denotes partially polymerized A6;A9 denotes filly polymerized clear lens; A10 denotes fully polymerizedA6. FIG. 3B depicts a method of applying ink to a surface.

FIG. 4 depicts a diagram of pad transfer printing method of the presentinvention. A7 denotes partially polymerized monomer mix for clear lens;A8 denotes partially polymerized color ink coat/layer of black, magenta,yellow and cyan; A9 denotes fully polymerized clear lens. A10 denotes afully polymerized A8.

FIG. 5 depicts a method of a lathe/fabrication process that can be usedto produce lens of the present invention.

FIG. 6 depicts cast molded method that can be used to produce lens ofthe present invention.

FIGS. 7A and 7B depict spin cast methods that can be used to producelens of the present invention.

FIG. 8A depicts examples of indentation structures that can be formed onthe convex portion of the present invention and are depicted as filledwith an ink of the present invention.

FIG. 8B depicts examples of indentation structures that can be formed onthe concave portion of the present invention and are depicted as filledwith an ink of the present invention. The indentation structures are notnecessarily shown to scale and preferably are relatively small such thatthey have a volume of less than about 10 microliters, less than about 5microliters, less than about 1 microliter, less than about 0.1microliter, less than about 1 nanoliter, less than about 0.1 nanoliteror less than about 0.01 nanoliters.

FIG. 9 depicts deposition of ink into a variety of indentationstructures of the present invention. Different angles represent rotationof surface. The indentation structures are represented as beingpartially filled with an ink of the present invention. The remainingvoid volume in the indentation structures can be filled with, forexample, a monomer or a polymer such as to trap the ink of the presentinvention. Droplets of one or more colors of ink can be deposited intosuch indentations to allow for a variety of colors to be present in suchindentations.

FIG. 10 depicts a fixture for centering and masking for lenses,preferably but not limited to hydrated or partially hydrated lenses.

FIG. 11 depicts schematic diagram of a variety of methods for printingdigitally encoded images in conjunction with the present invention.

FIG. 12 depicts schematic diagrams of a variety of methods of makingpolymers having printed digitally encoded images. A5 denotes a monomermix for clear lens.

FIG. 13 depicts diagram of laminate digitally encoded images within astructure of the present invention. A5 denotes a monomer mix for clearlens; A6 denotes color ink coat/layer of black, magenta, yellow andcyan; A7 denotes partially polymerized A5; A8 denotes partiallypolymerized A6; A9 denotes fully polymerized clear lens; A10 denotesfully polymerized A6.

FIG. 14 depicts printing methods within a well on a surface of thepresent invention. A5 denotes a monomer mix for clear lens; A6 denotescolor ink coat/layer of black, magenta, yellow and cyan; A7 denotespartially polymerized A5; A8 denotes partially polymerized A6; A9denotes fully polymerized clear lens.

SUMMARY

The present invention recognizes that lenses, such as contact lenses,can be tinted using ink that include polymers or polymerizable monomers,preferably the same monomers used to make the lens. The ink can be usedto make images on or within the lens. Images made using these inks arepreferably in a modified or unmodified digital format and can be used ina variety of printing methods, including inkjet printing. Modifieddigital formats can be made by altering the digital image before orafter printing such as by vibration applied to the printed surface.

A first aspect of the present invention is an article of manufacture,including: a polymer and a digitally encoded image made with ink,wherein the polymer forms a lens.

A second aspect of the present invention is a method of making anarticle of manufacture that includes a digitally encoded image and apolymer, including the steps of: printing a digitally encoded image on acomposition that includes a polymer, wherein the polymer forms a lens.

A third aspect of the present invention is a method of making an articleof manufacture that includes a digitally encoded image and a polymer,including the steps of: printing a digitally encoded image on acomposition comprising a polymer, and forming a lens from said polymer.

A fourth aspect of the present invention is a method of making anarticle of manufacture that includes a digitally encoded image and apolymer, including the steps of: printing a digitally encoded image on acomposition comprising at least one monomer, polymerizing said at leastone monomer to form at least one polymer, and forming a lens from saidat least one polymer.

A fifth aspect of the present invention is a method of making an articleof manufacture that includes a digitally encoded image and a polymer,including the steps of: printing an image on at least one first surface,transferring said image to at least one second surface comprising amonomer or a polymer, and forming a lens from said second surface.

A sixth aspect of the present invention is an article of manufacture,including: at least one information storage medium, and at least onedigital image, wherein the at least one digital image comprises at leasta portion of an image or other image.

A seventh aspect of the present invention is a system, including: anarticle of manufacture of the present invention and a printing device.

An eighth aspect of the present invention is a composition of matter,including an ink, dye, vat dye, particle, pigment, reactive dye or diazodye. The composition of matter also includes a binder, monomer, polymer,homopolymer, heteropolymer, copolymer, and initiator, UV initiator,thermal initiator, solvent, dispersant, anti-bacterial agent,anti-microbial agent, anti-fungal agent, disinfectant, thickener orhumectant.

A ninth aspect of the present invention is a method of doing business,including the steps of: obtaining a digital image from a person,database or image and printing said digital image on a lens.

DETAILED DESCRIPTION OF THE INVENTION

Definitions

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this invention belongs. Generally, the nomenclatureused herein and the laboratory procedures well known and commonlyemployed in the art. Conventional methods are used for these procedures,such as those provided in the art and various general references such asU.S. Pat. Nos. 5,160,463; 5,271,874; 5,018,849; 5,034,166; 5,414,477;Day et al., Current Optometric Information and Terminology, ThirdEdition, American Optometric Association (1980); Howley's CondensedChemical Dictionary (1981); and Federation of Societies for CoatingsTechnology, Glossary of Color Terms, Federation of Societies forCoatings Technology (1981). Where a term is provided in the singular,the inventors also contemplate the plural of that term. The nomenclatureused herein and the laboratory procedures described below are those wellknown and commonly employed in the art. As employed throughout thedisclosure, the following terms, unless otherwise indicated, shall beunderstood to have the following meanings:

“Directly” refers to direct causation of a process that does not requireintermediate steps.

“Indirectly” refers to indirect causation that requires intermediatesteps.

“Digitally Encoded Image” or “Digital Image” refers to an image that hasbeen created or stored in a digital format. A digitally encoded imagecan be made using methods known in the art, such as artistic renditionsor scanning or otherwise translating an image, including a naturallyoccurring image such as the iris of an eye, such as a human eye. Adigitally encoded image can be stored on appropriate storage medium,such as magnetic medium or polymers such as cyclolifin copolymers. Aplurality of digitally encoded images can be stored together orseparately to form a database of digitally encoded images that areaccessible individually or in combination. Such digitally encoded imagescan be altered using established methods, such as artistic renditions orimage modulating software. A plurality of images can also be merged toform a new digitally encoded image. A digital image is where a givenimage is presented as made from multiple dots of different colors. Forexample, an image produced by using a scanner or digital camera.Modified digital images may be defined as a digital image that ischanged with a secondary process like polymerization or mixing ofcolored dots.

“Ink” as used herein refers to any colored compound, chemical orstructure, such as a dye, vat dye, particle, pigment, reactive dye,diazo dye and the like. Ink also includes structures that while notcolored give the appearance of color by, for example, diffraction ordeflection (for example) of light by a particle. An ink can be waterbased, monomer based or solvent based.

“Dye” in the context of inks refers to a variety of dyes as they areknown in the art, such as diazo dyes, such as Diazo 15(4-diazo-(4′-toluyl)-mercapto-2,5-diethoxy benzyene zinc chloride) (U.S.Pat. No. 5,662,706).

“Vat Dye” in the context of inks refers to a variety of vat dyes as theyare known in the art, such as Vat Blue 6(7,16-dichloro-6,15-dihydro-9,14,18-anthrazinetertrone) and Vat Green 1(16,17-dimethyoxydinaphtho (1,2,3, ed: 31, 2′-1′-1-m)perylene-5) (U.S.Pat. No. 5,302,978).

“Particle” in the context of inks refers to a variety of particles asthey are known in the art, such as India Ink.

“Pigment” in the context of inks refers to a variety of pigments as theyare known in the art, such as titanium dioxide, red iron oxide, yellowiron oxide U.S. Pat. No. 5,160,463, Pigment Blue 15 (phthalocynine blue(CI# 74160)), Pigment Green 7 (thalocynine green (CI# 74260)), PigmentBlue 36 (cobalt blue (CI# 77343)) or chromium sesquioxide (U.S. Pat. No.5,272,010).

“Reactive Dye” in the context of inks refers to a variety of reactivedyes as they are known in the art, such as Reactive Blue No. 4(2-anthra-cene-sulfonic acid, 1-amino-4,3 ((4,6-dichloro-s-triazin-2-yl)amino)-4-sulfoaniline)-9-10-dihydro-9-10-dixo, disodium salt; CAS Reg.4499-01-8); Reactive Yellow No. 86 (1,3-ben-zendisulfonic acid 4-((5aminocarbonyl-1-ethyl-1,6-dihydro-2-hydroxy-4-methyl-6oxo-3-pridinyl)azo)-6-(4,6-dichloro-1,2,5-triazine-zyl)amino)-disodiumsalt) (U.S. Pat. No. 5,106,182).

“Solvent” in the context of inks refers to an aqueous, organic orinorganic solvent, such as water, isopropanol, tetrahydrofuran oracetone (U.S. Pat. No. 5,271,874).

“Surfactant” refers to a surfactant as that term is known in the art,such as, for example, acetylene glycol or polyoxyethylene alkyl ether(U.S. Pat. Nos. 5,746,818 and 5,658,376, respectively).

“Dispersant” in the context of inks refers to dispersants as they areknown in the art, such as, for example, the Tergitol series from UnionCarbide, polyoxylated alkyl ethers, alkyl diamino quarternary salts or“Pecegal “O”x” from GAF (U.S. Pat. No. 5,560,766). Dispersants arepreferably used at between about 0.1% and about 10%, more preferablybetween about 0.5% and about 5%.

“Lens” as used herein refers to a composition of matter that cantransmit light. A lens preferably can act as an optical lens, such as acontact lens. In certain aspects of the present invention, a lens neednot act as an optical lens, such as a contact lens that is used forvanity purposes as opposed to purposes relating to the correction,improvement or alteration of a user's eyesight.

“Contact Lens” refers to a structure that can be placed on or within awearer's eye. A contact lens can correct, improve, or alter a user'seyesight, but that need not be the case. A contact lens can be of anyappropriate material known in the art or later developed, and can be asoft lens, a hard lens or a hybrid lens. A contact lens can be in a drystate or a wet state.

“Soft Lens” refers to a variety of soft lenses as they are known in theart that are characterized as having, for example, at least one of thefollowing characteristics: oxygen permeable, hydrophilic or pliable.

“Hard Lens” refers to a variety of hard lenses as they are known in theart that are characterized as having, for example, at least one of thefollowing characteristics: hydrophobic, gas permeable or rigid.

“Hybrid Lens” refers to a variety of hybrid lenses as they are known inthe art, such as, for example, a lens having a soft skirt and a hardcenter.

“Dry State” refers to a soft lens in a state prior to hydration or thestate of a hard lens under storage or use conditions.

“Wet State” refers to a soft lens in a hydrated state.

“Single color” refers to a discrete color made of one or more ink.

“Multi-colored image” refers to an image that includes more than onesingle color. A multi-colored image can be made using a plurality ofsingle colors. For example, a multi-colored image can be made using twoor more single colors, three or more single colors, or four or moresingle colors, preferably primary colors. The colors can be mixed beforeor during the formation of a multi-colored image, such as during aprinting process, such as printing processes using dispensation, such asink jet printing.

“Transparent” refers to a substantial portion of visible lighttransmitted through a structure, such as greater than or equal to 90% ofincident light.

“Opaque” refers to a substantial portion of visible light reflected orabsorbed by a structure, such as greater than or equal to 90% ofincident light.

“Partially opaque” refers to a combination of transparent and opaque.

“Hydrogel” refers to a polymer that swells in an aqueous solution due tothe absorbance of water. A hydrogel includes water or an aqueoussolution as part of its structure.

“Polymer” refers to a linkage of monomers. Preferably, a polymer is apolymer appropriate for use in lenses, such as contact lenses. A polymercan be, for example, a homopolymer, a heteropolymer, a copolymer, ahydrophobic polymer, a hydrophilic polymer or any combination thereof.

“Hydrophobic Polymer” refers to a polymer that does not absorb anappreciable amount of water or an aqueous solution (see, U.S. Pat. No.5,034,166). “Hydrophilic Polymer” refers to a polymer that absorbs anappreciable amount of water or an aqueous solution (see, U.S. Pat. No.5,034,166). Lens forming materials that are suitable in the fabricationof contact lenses are illustrated by one or more of the following U.S.Pat. Nos. 2,976,576; 3,220,960; 3,937,680; 3,948,871; 3,949,021;3,983,083; 3,988,274; 4,018,853; 3,875,211; 3,503,942; 3,532,679;3,621,079; 3,639,524; 3,700,761; 3,721,657; 3,758,448; 3,772,235;3,786,034; 3,803,093; 3,816,571; 3,940,207; 3,431,046; 3,542,461;4,055,378; 4,064,086; 4,062,624; and 5,034,166.

“Hydrophilic Monomer” refers to monomers used to make soft lenses, suchas hydroxyethylmetheylacrylate, methaerylic acid or n-vinylpyrrolidone(U.S. Pat. Nos. 5,271,874; 5,272,010). “Hydrophilic Monomer” refers tomonomers used to make hard lenses, such as methylmethacrylate,ethoxyethyl methacrylate, styrene or silicone (U.S. Pat. Nos. 5,271,874;5,272,010).

“Homopolymer” refers to a polymer comprising a single type of monomersuch as hydroxyethylmethyl acrylate.

“Heteropolymer” refers to a polymer comprising more than one type ofmonomer such as hydroxyethylmethylacrylat and mehtylacrylic acid.

“Copolymer” refers to the use of two different polymers to make apolymer chain.

“Acrylic Polymer” or “Acrylics” refers to a variety of polymer of thatgenus and species as they are known in the art, such as, for example,hydroxylethylmethyle acrylate.

“Silicone Polymer” or “Silicones” refers to a variety of polymers ofthat genus and species as they are known in the art, such as, forexample Tris (such as Tris(pentamethyldisiloxyanyl)-3-methacrylate-propylsilane or3-methacryloxypropy tris(trimethylsiloxy)silane).

“Polycarbonate Polymer” or “Polycarbonate” refers to a variety ofpolymers of that genus and species as they are known in the art, suchas, for example Lexan.

“Initiator” in the context of polymerization refers to an initiator asthat term is known in the art, such as, for example, a chemical thatstarts a polymerization reaction.

“UV Initiator” in the context of polymerization refers to a UV initiatoras that term is known in the art, such as, for example, a chemical thatbecomes reactive or active with the adsorption of energy, such as UVenergy, such as, for example benzoin methyl ether.

“Binder” or “bonding agent” refers to compounds used perform thefunction of increasing the interaction between moieties, such as betweena dye and a polymer or monomer or between monomers and polymers such asthose terms are known in the art. Examples of binders or binding agentsare hexamethylene diisocyanate or other isocyanate compounds.

“Thickener” refers to compounds that is used to increase the viscosityof a liquid or partially liquid mixture or solution such as that term isknown in the art. An example of a thickener are polyvinyl alcohols.

“Anti-kogating agent” or “non-kogating agent” refers to compounds thatfacilitate printing processes that utilize nozzles, such as such termsare known in the art.

“Dispersant” refers to a surface active agent added to a suspendingmedium to promote the distribution and separation of fine or extremelyfine solid particles.

“Thermal Initiator” in the context of polymerization refers to a thermalinitiator as that term is known in the art, such as, for example, achemical that becomes active or reactive with the absorption of heatenergy, such as, for example, Vazo-64 or azobisilobutyronitrile.

“Anti-Bacterial Agent” refers to a compound or composition that can actas a bactericidal or bacteriostatic or can reduce the growth rate of abacteria such as tetrabutylamonium chloride.

“Anti-Fungal Agent” refers to a compound or composition that can act asa fungicidal or fungalstatic or can reduce the growth rate of a fungisuch as benzakonium chloride salicylic acid.

“Disinfectant” refers to a compound or composition that can reduce thetype, number or diversity of microorganisms.

“Humectant” refers to compounds that reduce evaporation, such asethylene glycol.

“Printing” refers to the application of at least one ink to a surface orstructure to form an image. Printing can use any appropriate device ormethod known in the art of later developed for a particular purpose.

“Printing Device” refers to any appropriate device for printing an imageon a surface or structure known in the art or later developed for aparticular purpose. Preferably, a printing device includes thedispensation of microdroplets of liquid that includes an ink that forman image. The size or volume of the microdroplets can vary, butgenerally the smaller the microdroplet, the higher the quality of theimage produced. Preferred microdroplets are between about 1 nanoliterand about 100 microliters, preferably between about 10 nanoliters andabout 10 microliters or between about 100 nanoliters and about 1microliter.

“Ink Jet Printing” refers to printing using a printing device thatcomprises at least one ink jet. Ink jet printing can use a single coloror can use a plurality of colors. For example, ink jet printing can usea printing device that contains a plurality of different colored inksthat can be provided separately. In this aspect of the invention, theinks are preferably at least two, at least three or at least fourprimary colors and black that can be mixed to form a very large numberof different colors. Such printing devices are commercially availablesuch as through, for example, Hewlett Packard Corporation (such asDeskJet 560C printer cartridges) and Encad Corporation. Ink can beapplied to a surface more than once to obtain the desired intensity, hueor other color characteristic.

“Piezo Printing” refers to printing using a printing device thatcomprises at least one piezo printing structure. Such piezo printingstructures are known in the art, such as, for example, those availablethrough Packard Instruments and Hewlett Packard Corporation or CanonInc.

“Thermal Printing” refers to printing using a printing device thatcomprises at least one thermal printing structure. Such thermal printingstructures are known in the art, such as, for example, those availablethrough Hewlett Packard Corporation.

“Laser Printing” refers to printing using a printing device that uses atleast one laser printing structure. Such printing structures are knownin the art, such as, for example, those available through Cannon orHewlett Packard Corporation.

“Pad Transfer Printing” refers to printing using a pad transfer printingdevice. Such pad transfer printing devices are known in the art,particularly for printing in the field of contact lenses. Briefly, animage is placed or printed on a pad transfer device and the image on thepad transfer device is transferred to another surface, such as a polymeror lens (U.S. Pat. No. 3,536,386 to Spivack, issued Oct. 27, 1970; U.S.Pat. No. 4,582,402 to Knapp, issued Apr. 15, 1986; U.S. Pat. No.4,704,017 to Knapp, issued Nov. 3, 1987; U.S. Pat. No. 5,034,166 toRawlings et al., Jul. 23, 1991; U.S. Pat. No. 5,106,182 to Briggs etal., issued Apr. 21, 1992; U.S. Pat. No. 5,352,245 to Su et al., issuedOct. 4, 1994; U.S. Pat. No. 5,452,658 to Shell, issued Sep. 26, 1995 andU.S. Pat. No. 5,637,265 to Misciagno et al., issued Jun. 10, 1997).

“Impregnation” refers to an ink being contacted with a surface, such asa polymer, and the ink diffuses into the polymer where it is reacted toprecipitate to a size larger than the average pore size of the polymer(EP 0357062 to Pfortner, published Mar. 7, 1990).

“Photolithography” refers to a process as it is known in the art, suchas wherein at least one photosensitive ink is used to provide a desiredimage using a mask that blocks light.

“Chemical Bond” refers to a covalent bond or non-covalent bond. Undercertain circumstances, inks can form chemical bonds with polymers ormonomers if the reactive groups on each are appropriate (EP 0393532 toQuinn, published Oct. 24, 1990 (referring to U.S. Pat. No. 4,668,240 toLoshaek and U.S. Pat. No. 4,857,072); U.S. Pat. No. 5,272,010 to Quinn,issued Dec. 21, 1993;

“Polymer-Polymer Bond” refers to two polymers forming covalent ornon-covalent bonds, such as by cross linking polymers formed between twopolymers, such as hydroxyethyl methylacrylate andehtyleneglycoldimethacrylate.

“Pattern” refers to a predetermined image (U.S. Pat. No. 5,160,463 toEvans et al., issued Nov. 3, 1992; U.S. Pat. No. 5,414,477 to Jahnke,issued May 9, 1995;).

“At least two separate colors or a mixture thereof,” “at least threeseparate colors or a mixture thereof,” or “at least four separate colorsor a mixture thereof” refers to the use of inks of different colorsbeing provided in separate containers or separate portions within acontainer. The colors are preferably primary colors or fundamentalcolors and black, more preferably black, cyanine, magenta and yellow.The inks can be mixed in different proportions (including zero) toobtain a very large spectrum of colors. The mixing can occur within aprinting structure, for example, before the ink is dispensed in aprinting process. Alternatively, the mixing can occur outside of aprinting structure, for example, after the ink is dispensed in aprinting process. Furthermore, a combination of the foregoing can alsooccur.

“Dry State” refers to a polymer that is not fully hydrated.

“Wet State” refers to a polymer that is fully hydrated.

“Forming a Lens” or “Fabricating a Lens” refers to any method orstructure known in the art or later developed used to form a lens. Suchforming can take place, for example, using cast-molding, spin-casting,cutting, grinding, laser cutting, stamping, trimming, engraving, etchingor the like (U.S. Pat. No. 4,558,931 to Fuhlman, issued Dec. 17, 1985).

“Cast-Molding” in the context of forming a lens refers to the formationof at least a portion lens using a mold (U.S. Pat. No. 3,536,386 toSpivak, issued Oct. 27, 1970; U.S. Pat. No. 3,712,718 to LeGrand et al.,issued Jan. 23, 1973; U.S. Pat. No. 4,582,402 to Knapp, issued Apr. 15,1986; U.S. Pat. No. 4,704,017 to Knapp, issued Nov. 3, 1987; U.S. Pat.No. 5,106,182 to Briggs et al., issued Apr. 21, 1992; U.S. Pat. No.5,160,463 to Evans et al., issued Nov. 3, 1992; U.S. Pat. No. 5,271,874to Osipo et al., issued Dec. 21, 1993 and EP 0357062 to Pfortner,published Mar. 7, 1990)

“Spin-Casting” in the context of forming a lens refers to the formationof a lens using centrifugal force (U.S. Pat. No. 3,557,261 to Wichterle,issued Jan. 19, 1971 and U.S. Pat. No. 5,034,166 to Rawlings et al.,issued Jul. 23, 1991).

“Information Storage Medium” refers to any medium of expression that canstore information in any appropriate format either permanently ortransiently. Preferred information storage medium includes paper,electronic medium, magnetic medium or polymers, such as cyclolifincopolymers.

“Electronic Medium” refers to information storage medium that can storeinformation in electronic form. For example, electronic medium includesmagnetic storage medium, such as diskettes.

“Machine Readable Format” refers to information stored on or within aninformation storage medium in a form, language or arrangement such thata machine, such as a central processing unit (CPU) can access and usethe information.

“Database” refers to a collection of information, such as digitalimages. The information is preferably provided on or within aninformation storage medium and can be separate from or integral with acentral processing unit.

Other technical terms used herein have their ordinary meaning in the artthat they are used, as exemplified by a variety of technicaldictionaries.

Introduction

The present invention recognizes that lenses, such as contact lenses,can be tinted using ink that include polymers or polymerizable monomers,preferably the same monomers used to make the lens. The ink can be usedto make images on or within the lens. Images made using these inks arepreferably digital and can be used in a variety of printing methods,including ink-jet printing.

As a non-limiting introduction to the breath of the present invention,the present invention includes several general and useful aspects,including:

1) an article of manufacture, including: a polymer and a digitallyencoded image made with ink, wherein the polymer forms a lens;

2) a method of making an article of manufacture that includes adigitally encoded image and a polymer, including the steps of: printinga digitally encoded image on a composition that includes a polymer,wherein the polymer forms a lens, wherein such lenses can optionallyinclude indentation structures to facilitate localizing inks used tomake the digitally encoded image;

3) a method of making an article of manufacture that includes adigitally encoded image and a polymer, including the steps of: printinga digitally encoded image on a composition comprising a polymer, andforming a lens from said polymer;

4) a method of making an article of manufacture that includes adigitally encoded image and a polymer, including the steps of: printinga digitally encoded image on a composition comprising at least onemonomer, polymerizing said at least one monomer to form at least onepolymer, and forming a lens from said at least one polymer;

5) a method of making an article of manufacture that includes adigitally encoded image and a polymer, including the steps of: printingan image on at least one first surface, transferring said image to atleast one second surface comprising a monomer or a polymer, and forminga lens from said second surface;

6) an article of manufacture, including: at least one informationstorage medium, and at least one digital image, wherein the at least onedigital image comprises at least a portion of an image or other image;

7) a system, including: an article of manufacture of the presentinvention and a printing device;

8) a composition of matter, including an ink, dye, vat dye, particle,pigment, reactive dye or diazo dye. The composition of matter alsoincludes a binder, bonding agent, monomer, polymer, homopolymer,heteropolymer, copolymer, and initiator, UV initiator, thermalinitiator, solvent, dispersant, surfactant, anti-bacterial agent,anti-microbial agent, anti-fungal agent, disinfectant, thickener orhumectant; and

9) a method of doing business, including the steps of: obtaining adigital image from a person, database or image and printing said digitalimage on a lens.

These aspects of the invention, as well as others described herein, canbe achieved by using the methods, articles of manufacture andcompositions of matter described herein. To gain a full appreciation ofthe scope of the present invention, it will be further recognized thatvarious aspects of the present invention can be combined to makedesirable embodiments of the invention.

I Lens With Digitally Encoded Image

The present invention includes an article of manufacture, including: apolymer and a digitally encoded image comprising at least one ink,wherein the polymer forms a lens.

Digitally Encoded Image

The digitally encoded image can include a single color image or amulti-colored image. The single color image preferably comprises oneink, but that need not be the case because many inks have similar colorsand different colored inks can be combined to produce an ink with acolor different from the individual inks used to make the combination.The multi-colored image is preferably made using a plurality of inkseither alone or in combination.

The digitally encoded image can be transparent, opaque or partiallyopaque. For transparent digitally encoded images, the ink within theimage does not substantially interfere with the transmission of lightthrough the polymer. For opaque digitally encoded images, the ink withinthe digitally encoded image substantially interferes with thetransmission of light through the polymer. When the lens is a contactlens, opaque digitally encoded images can substantially block thenatural color of the contact lens wearer's iris. Ink used to create anopaque digitally encoded image can include materials such as particles,for example as mica or ground oyster shells or particulates, in a typeand amount sufficient to make the digitally encoded image opaque.Another alternative is a pigment, vat dye, diazo dye or reactive dye.For partially opaque digitally encoded images, the ink within thedigitally encoded image can include materials such as particles andparticulates, such as mica, ground oyster shells or particulates, in atype and amount sufficient to partially block the transmission of lightthrough the digitally encoded image. Partially blocking the transmissionof light, in this instance, refers to the ability of the digitallyencoded image to allow a portion of incident light to transmit through adigitally encoded image.

Ink

Inks used in the present invention can include any single coloredcompound or composition or any combination of colored compounds orcompositions. Inks can be provided in water, monomer or solvents,preferably at a concentration between about 0% and greater than about99.5% or between about 0.01% and about 99.5%, preferably between about0.1% and about 90% or between about 1% and about 80%, and morepreferably between about 10% and about 60% or between about 20% andabout 40%. Inks can also include particles or particulates, preferablyat a concentration of between about 0% and about 5% or between about0.01% and about 5%, preferably between about 0.1% and about 4% orbetween about 1% and about 3% to render a digitally encoded image opaqueor partially opaque. Examples of inks include dyes, vat dyes, particles,pigments, reactive dyes or diazo dyes. As discussed herein, thecharacteristics and compositions including inks and other componentsinclude inks that are part of an article of manufacture of the presentinvention, such as a lens, such as a contact lens, and also includecompositions that include at least one ink that can be used to make anarticle of manufacture of the present invention.

Inks can include water, monomer, polymer or an appropriate solvent inorder for the ink to be suitable in the making of a digitally encodedimage. An appropriate solvent is a solvent that is compatible with thecreation of a digitally encoded image on or within a surface, such as onor within a polymer. For example, solvents appropriate for polymers usedto make lenses, such as contact lenses, include, but are not limited toisopropanol, water, acetone or methanol, either alone or in combinationand can include a monomer. Appropriate concentrations of solvents arebetween about 0% and greater than about 99.5% or between about 0.1% andabout 99.5%, preferably between about 1% and about 90% or between about10% and about 80%, and more preferably between about 20% and about 70%or between about 30% and about 60%. Different polymers, monomer and inkshave different tolerances and reactivities to different solvents. Thus,appropriate matches between solvent and polymer, monomer and ink shouldbe considered. For hydrogel polymers, adjustment in swelling ratios maybe achieved with a variety of concentrations of solvents.

An ink can also include a monomer, polymer, homopolymer, heteropolymeror copolymer. In a preferred aspect of this embodiment of the presentinvention, an ink includes a monomer that can be polymerized to form apolymer using polymerization methods appropriate for a given monomer,mixtures thereof, or polymers, or mixtures thereof Monomers can also beused to decrease the viscosity of the ink. Alternatively, the ink caninclude a polymer such that the viscosity of the ink is increased.Alternatively, the ink can include polymer and monomer. Appropriateconcentrations of monomers are between about 5% and greater than 99%,preferably between about 25% and about 75%, and more preferably betweenabout 35% and about 60%. Appropriate concentrations of polymers arebetween about 0% and about 50%, preferably between about 5% and about25%, and more preferably between about 10% and about 20%. When monomersand polymers are mixed, the total concentration of monomer and polymerare between about 10% and greater than 99%, preferably between about 25%and about 75% and more preferably between about 35% and about 65%.

The viscosity of a solution including an ink can be as high as betweenabout 500 centipoise and about 5,000 centipoise and is preferablybetween about 1 to about 200 centipoise or between about 10 and about 80centipoise, preferably between about 20 and about 70 centipoise orbetween about 30 and about 60 centipoise or between about 1 and about 10centipoise. Solutions having low viscosity tend to be “runny” whendispensed, and can allow different colors to merge and blend, resultingin an image with a more natural appearance. Such blending can beenhanced using a variety of methods, including sonication or vibrationat appropriate duration and frequency to promote appropriate blending.Solutions having too low a viscosity can result in images that are too“runny” and thus have potentially undesirable characteristics, such aspooling of ink in a digitally encoded image or spreading of ink to anunintended location. Solutions having too high a viscosity may not beeasily dispensed using a variety of printing structures, such as inkjets and thus may not be appropriate for the present invention.Furthermore, solutions having high viscosity can tend to “bead” on asurface and not blend with the surrounding environment, includingsurrounding droplets or beads of ink. Under these circumstances, the inkmay form unnatural appearing images (see, for example, U.S. Pat. Nos.5,160,463 and 5,414,477). Agents such as thickeners or diluents(including appropriate solvents) can be used to adjust the viscosity ofthe ink.

An ink that includes at least one monomer can also include apolymerization initiator, so that once an ink that includes at least onetype of monomer is dispensed, the polymerization of the monomer in theink is initiated. The number, type and amount of initiator is a matterof choice depending on the type of monomer or monomers in the ink.Appropriate initiators include, but are not limited to, UV initiatorsthat initiate polymerization by UV irradiation, thermal initiators thatinitiate polymerization by thermal energy.

An ink can also include a dispersant to allow uniform composition of inkin a container. Dispersants are preferably provided at an appropriateconcentration, such as between about 1% and about 10%.

An ink can also include at least one anti-microbial agent or antisepticagent to kill or reduce the number or multiplication microbial agents,reduce the number of microbial agents, or keep microbial agents frommultiplying. Preferred anti-microbial agents include anti-bacterialagents, anti-fungal agents and disinfectants. Preferably, suchanti-microbial agents, anti-bacterial agents, anti-fungal agents anddisinfectants are provided at an appropriate concentration such asbetween about 0% and about 1%.

An ink can also include at least one humectant such as1,3-diozane-5,5-dimethanol (U.S. Pat. No. 5,389,132) at an appropriateconcentration. Preferably, the range of concentration of a humectant isbetween about 0% and about 2%.

An ink can also include at least one antioxidant agent or a lowcorrosion agent, such as alkylated hydroquinone, at an appropriateconcentration, such as between about 0.1% and about 1% (U.S. Pat. No.4,793,264). An ink can also include a non-kogating agent or non-kogatingagent, such as 2-methyl-1,3-propanediol at an appropriate concentration,such as between about 0% and about 1%. An ink can also include anevaporation retarding agent, such as, for example, diethylene glycerolor ethylene glycol at between about 0% and about 2% (U.S. Pat. No.5,389,132).

A preferred ink can have the following composition:

Component Percentage Monomer  0% to 99% Pigment and/or colorant 0.1% to15%  and/or reactive dye Initiator 0.01% to 2%   Solvent  0% to 80%Binder or Bonding Agent  0% to 10% Thickener 0% to 1% Anti-kogatingAgent 0% to 1% Humectant 0% to 1% Surfactant  0% to 10% Cross-linker 0%to 1% Dispersant  0% to 10%

Printing

The digitally-encoded image is preferably applied to a structure, suchas a lens, using a printing method or printing structure. The digitallyencoded image can be stored digitally in at least one informationstorage medium, such as an electronic medium. The stored digitallyencoded image can be printed using printing structures and printingmethods that can convert the stored digitally encoded image into aprinted image using an appropriate interface. For example, a centralprocessing unit can include a stored digitally encoded image. Softwarecan interface the stored digitally encoded image with a printingstructure such that the printing structure prints the digitally encodedimage. Such interfaces are known in the art, such as those used indigital printing processes that use ink-jets (Hewlett Packard; Encad)(see, for example, FIG. 1.

Preferred printing methods and printing structures include, but are notlimited to, ink-jet printing, piezo printing, thermal printing, bubblejet printing, pad-transfer printing, impregnation, photolithography andlaser printing. Ink-jet printing can use appropriate ink-jet printingstructures and ink-jet printing methods as they are known in the art orlater developed. For example, appropriate ink-jet printing structuresinclude, but are not limited to HP Desk Jet 612 or Cannon color bubblejet BJC1000 color printer hardware. Furthermore, appropriate ink-jetprinting methods, include, but are not limited to thermal ink jetprinting, piezo printing or bubble jet printing.

Ink-jet printing can include piezo printing structures and piezoprinting methods as they are known in the art or later developed. Forexample, appropriate piezo printing structures include, but are notlimited to Cannon color bubble jet printer BJC1000.

Ink-jet printing can include thermal printing structures and thermalprinting methods as they are known in the art or later developed. Forexample, appropriate thermal printing structures include, but are notlimited to HP Deskjet 612 color printer.

Ink-jet printing can include bubble jet printing structures and bubblejet printing methods as they are known in the art or later developed.For example, appropriate thermal bubble jet structures include, but arenot limited to Cannon BJC1000 color printer.

Pad-transfer printing can include pad-transfer printing structures andpad-transfer printing methods as they are known in the art or laterdeveloped. For example, appropriate pad-transfer printing structuresinclude, but are not limited to Tampo-type printing structures (Tampovario 90/130), rubber stamps, thimbles, doctor's blade, direct printingor transfer printing as they are known in the art.

Impregnation printing can include impregnation printing structures andimpregnation printing methods as they are known in the art or laterdeveloped. For example, appropriate impregnation printing structuresinclude, but are not limited to applying solubilized vat dyes, maskingdevice, developer and the like.

Photolithography printing can include photolithographic printingstructures and photolithography printing methods as they are known inthe art or later developed. For example, appropriate photolithographyprinting structures include, but are not limited to applying diazo dyes,masking devices, developers and the like.

Laser printing can include laser printing structures and laser printingmethods as they are known in the art or later developed. For example,appropriate laser printing structures include, but are not limited to HPLaser Jet printer hardware, particularly the 4L, 4M series.

More than one printing structure or more than one printing method can beused to make a digitally encoded image of the present invention. Forexample, ink-jet printing and pad transfer printing can be used incombination.

Digitally encoded images can be printed on the surface of a structure,such as on the surface of a lens, such as on the surface of a contactlens. In this aspect of the present invention, the printing structuresand printing methods deposit ink onto a surface. The ink can then dry toproduce a non-transient image, or monomers or polymers within the inkcan be polymerized to produce a non-transient image. In the latterinstance, the monomers or polymers are preferably the same or result inthe same polymer that comprises the surface. Digitally encoded imagescan be printed on at least one surface of a structure. For example, ifthe structure is a lens, such as a contact lens, a digitally encodedimage can be printed on either or both sides of the contact lens.Printing methods preferred for this type of printing include, but arenot limited to thermal inkjet or bubble jet printing.

As depicted in FIG. 2, digitally encoded images can also be trappedwithin a structure, such as a lens, such as a contact lens. In thisaspect of the present invention, the image can be trapped within astructure using laminate printing, including sandwich laminate printing.For example, an image is printed on a surface, such as a first portionof a lens, then a second portion of a structure, such as a secondportion of a lens, is attached to the first portion of a lens such thatthe image is trapped between the first portion of a structure and thesecond portion of a structure.

Preferably, the first portion of a structure includes a polymer and thedigital image includes a monomer. The monomer can be polymerized suchthat the digitally encoded image becomes non-transient and substantiallyimmobile. Then the second portion of a lens is attached to the firstportion of a structure such that the digitally encoded image becomestrapped between the first portion of the structure and the secondportion of a structure. In this aspect of the present invention, thedigitally encoded image preferably includes a monomer that can bepolymerized to form a polymer, preferably a polymer that is included inthe first portion of a structure or the second portion of a structure,preferably both.

In a preferred aspect of the present invention, the first portion of astructure is a non-polymerized monomer or semi-polymerized polymer thatincludes monomer onto which the digitally encoded image, whichpreferably comprises the same monomer as the first portion of astructure, is printed. This composite structure can be partially orfully polymerized and a second portion of a structure attached theretoto entrap the digitally encoded image therein. In the alternative, thesecond portion of a structure, which preferably includes monomer andoptionally polymer, preferably the same as the first portion of a lensand the digitally encoded image, is contacted with this first portion ofa structure and digitally encoded composite such that the digitallyencoded image is trapped between the first portion of a structure andthe second portion of a structure. The resulting laminate compositestructure includes a digitally encoded image trapped within thestructure. In one aspect of the present invention a partiallypolymerized layer of ink is contacted with a monomer, or alternatively amonomer is partially polymerized and contacted with a layer of ink. Eachcombination can be partially polymerized and transferred to a primarysurface and fully polymerized such that the polymerized layer of ink issandwiched in between a polymer layer and the primary polymerizedsurface (see, for example, FIG. 3).

The laminate composite structure can be fashioned into a lens usingmethods described herein and as they are known in the art or laterdeveloped, such as, for example, laser cutting, stamping, grinding,polishing or the like. In the alternative, the laminate compositestructure made using the foregoing methods results in a lens. Forexample, the laminate composite can be made in a mold that has the shapeof a lens. Such molds are known in the art and have been describedherein. In the alternative, the method used to make the laminate canform a lens, such as spin-casting methods.

Lenses made using spin casting are preferable in the present method. Inthe alternative, other appropriate methods, such as those describedherein, known in the art, or later developed, that can form at least aportion of a lens can also be used. In this aspect of the presentinvention, a first portion of a structure is printed with a digitallyencoded image and the second portion of a structure is added thereon toform a laminate structure. Spin-casting or other lens forming methodsand polymerizing can optionally take place any time during this processand the first portion the structure, the second portion of a structureand the digitally encoded image can be in various states ofpolymerization, such as non-polymerized, partially polymerized orpolymerized. Optionally, the digitally encoded image need not includemonomer or polymer.

For example, a first portion of a structure can be non-polymerized,polymerized or partially polymerized and can be spin-cast (or other lensforming method) or not spin-cast (or other lens forming method). Adigitally encoded image including or not including a monomer and/or apolymer can be printed on the first portion of a lens to form acomposite. This composite can be polymerized, not polymerized orpartially polymerized and can optionally be spin-cast (or other lensforming method) or at least a portion of a lens formed by anotherappropriate method (the optional polymerization and optionalspin-casting (or other lens-forming method) can take place in eitherorder). This composite is then contacted with a second portion of astructure that can be polymerized, partially polymerized ornon-polymerized and then can be optionally spin-cast (or other lensforming method) to form a portion of a lens to form a compositelaminate. The composite laminate, or at least a portion thereof, is orare optionally polymerized. Preferably, the first portion of astructure, the digitally encoded image and the second portion of astructure all share at least one common monomer or polymer, but thatneed not be the case.

One example of this method includes a first portion of a structuredispensed into a receiving structure such as a mold, wherein the firstportion of a structure is non-polymerized, partially polymerized orpolymerized and is not spin-cast (or other method of forming at least aportion of a lens). The digitally encoded image is printed on the firstportion of a structure, wherein the digitally encoded image optionallyincludes a monomer and/or a polymer to form a composite structure. Asecond portion of a structure is contacted with the composite structure,wherein the second portion of a structure is non-polymerized, partiallypolymerized or polymerized to form a laminate composite. The laminatecomposite is then spin-cast (or other method of forming at least aportion of a lens).

Another example of this method includes a first portion of a structuredispensed into a receiving structure, such as a mold, wherein the firstportion of a structure is non-polymerized or partially polymerized andis optionally spin-cast (or other method of forming at least a portionof a lens) and is optionally polymerized. The digitally encoded image isprinted on the first portion of a structure, wherein the digitallyencoded image optionally includes a monomer and/or a polymer to form acomposite structure and is optionally spin-cast (or other method offorming at least a portion of a lens) and optionally polymerized. Asecond portion of a structure is contacted with the composite structure,wherein the second portion of a structure is non-polymerized, partiallypolymerized or polymerized to form a laminate composite. The laminatecomposite is optionally spin-cast (or other method of forming at least aportion of a lens). Preferably, the first portion of a structure andsecond portion of a structure include the same or similar monomer andpolymer and are partially polymerized such that a polymerization (suchas a final polymerization of a laminate structure) results in arelatively or substantially “seamless” laminate structure (fused orconnected). Preferably, the digitally encoded also includes the same orsimilar monomer and polymer (non-polymerized or partially polymerized)so that a polymerization (such as a final polymerization of a laminatestructure) results in a relatively or substantially “seamless” laminatestructure.

During this course of this method, the digitally encoded image can forma chemical bond with either or both of the first portion of a structureand the second portion of a structure. In this instance, the digitallyencoded image comprises an ink that can form such a chemical bond.

Also, the digitally encode image can form a polymer-polymer bond witheither one or both the first portion of a structure and second portionof a structure. In this instance, the digitally encoded image includes amonomer or polymer that formed a polymeric bond with at least one of thefirst portion of a structure and second portion of a structure.

In this aspect of the invention, the digitally encoded image preferablyincludes at least one pattern. The pattern can be any pattern, includingnaturally and non-naturally occurring patterns. For example, a naturallyoccurring pattern can include a fractile-like pattern. Non-naturallyoccurring patterns can include geometric patterns or non-geometricpatterns, such as are used in vanity contact lenses. A digitally encodedimage can include at least one color, but preferably includes aplurality of colors. A digitally encoded image preferably includes atleast a portion of an image of an eye, such as the iris of an eye, suchas the iris of a human eye.

The image can include at least one color, but preferably includes two ormore colors. The colors used in the image can be derived from a mixtureof separate colors, such as two or more separate colors, three or moreseparate colors or four or more separate colors. For the purposes ofthis aspect of the invention, black is considered a separate color. Theseparate colors are preferably primary colors that can be mixed indifferent proportions to form a wide array of colors on an image.

Polymers and Lenses

Structures, such as lenses, of the present invention preferably includeat least one polymer. When the structure of the present invention is alens, such as a contact lens, the at least one polymer is preferably apolymer that is compatible with the eye. Preferable polymers for use inmaking contact lenses include, but are not limited to acrylics,silicones, polycarbonates and others known in the art or laterdeveloped. Polymers useful in the present invention can be hydrophobicor hydrophilic. In the case of hydrophilic polymers, the polymerpreferably forms a hydrogel. Generally, polymers used to make contactlenses result in “hard lenses,” “soft lenses” or “hybrid lenses” asthose terms are known in the art.

II Method of Making a Lens with a Digitally Encoded Image-I

The present invention also includes a method of making an article ofmanufacture that includes a digitally encoded image and a polymer,including the steps of printing a digitally encoded image on acomposition that includes a polymer, wherein the polymer forms a lens.The polymer can be any polymer, but is preferably a polymer in a wetstate or a dry state, such as polymers used in the manufacture oflenses, such as contact lenses.

The article of manufacture is made by providing a composition thatincludes a polymer that the digitally encoded image is to printed upon.The polymer is preferably a polymer used to make lenses, such as contactlenses, and include, but are not limited to, hydrophobic polymers,hydrophilic polymers, homopolymers, heteropolymers, copolymers, acrylicpolymers, silicone polymers or polycarbonate polymers either alone or incombination. One preferred lens includes the following: HEMA(hydroxyekyl methaenylate), EOEMA (ethoxyethylmethacrylate, MAA(methacrylic acid), EGDMA (ethylene glycoldimethacrylate), Vazo-64(azobisilobutyronitrile), BME (benzoin methylether), IPA (isopropylalcohol), THF (terahydrofuran), Mercap-2 (mercaptoethanol), c-pentanone(cyclopentanone) and MEHQ (methylethyl hydroquinone) (see U.S. Pat. No.5,271,874).

In this aspect of the present invention, the polymer at least in partforms a lens, such as a contact lens, such as a soft contact lens, ahard contact lens or a hybrid contact lens. It is the structure thatforms at least in part a lens that a digitally encoded image is printed.Preferably, the digitally encoded image is printed on the lens and canbe printed on either or both sides of the lens. The digitally encodedimage can be printed on the entire lens or a portion thereof. Forexample, the digitally encoded image can depict the iris of an eye suchthat the area corresponding the pupil of the eye is not printed.

The digitally encoded image is preferably encoded electronically, suchas in a database. The digitally encoded image can be prepared by anyappropriate method, such as by scanning an image into a processing unitusing appropriate scanning and storage hardware and software. Thedigitally encoded image can be selected and can be conveyed to aprinting device as an electronic signal using appropriate hardware andsoftware.

The digitally encoded image is preferably printed using a printingdevice that is capable of producing a digital image, such as an ink jetprinting device, a piezo printing device, a thermal printing device or alaser printing device. The printing devices preferably include at leastone ink, wherein if more than one ink is present in such printingdevice, the different inks are provided in separate containers orseparate portions of the same containers, such as provided in HewlettPackard Color DeskJet printer cartridges (HP51649A).

An ink preferably contains at least one monomer, such as a hydrophobicmonomer or hydrophilic monomer that preferably correspond to a polymerthat is included in the lens. The ink can also include a variety ofother components, such as an appropriate initiator, such as a UVinitiator or a thermal initiator to initiate polymerization of themonomer after being dispensed by a printing device on a polymer. An inkcan optionally also include at least one of a binder, an ant-bacterialagent, an anti-fungal agent, a disinfectant or a humectant at anappropriate concentration for the intended function. Preferably inksinclude, but are not limited to, pigment black 7 (carbon black), pigmentblack 11 (iron oxide), pigment brown 6 (iron oxide), pigment red 101(iron oxide), pigment yellow 42 (iron oxide), pigment while 6 (titaniumdioxide), pigment green 17 (chromium oxide), pigment blue 36 (chromiumaluminum cobaltous oxide), pigment blue 15 (copper phthaloxyanine),pigment violet 23 (3,amino-9-ethyl carbazole-chloronil) (U.S. Pat. No.5,302,479), Millikan ink yellow 869, Millikan ink blue 92, Millikan inkred 357, Millikan ink black 8915-67 (see U.S. Pat. No. 5,621,022).

Preferably, four separate ink colors, which can include one or moreindividual inks, are used in a printing device FIG. 1. The four inkscorrespond to black, magenta, yellow and cyan. The printing device canmix these inks to provide a wide diversity of colors for use in theprinting process. A typical ink formulation includes: monomer (HEMA),initiator (BME), crosslinker (EGDMA), pigment #1 (pthalocynine blue),diluent (glycerine), solvent (isopropanol), pigment #2 (titaniumdioxide), dispersant (polyvinyl alcohol), humectant (ethylene glycol),co-monomer (methacrylic acid), inhibitor (MEHQ), anti-kogating agent(methylpropanediol) and anti-oxidant (alkylated hydroquinone). Themonomer can also be a mixture of two or more monomers. A preferred mixof monomers that results in a clear polymer, such as for a clear contactlens, include monomer HEMA (hydroxyethyl methacrylate), monomer EOEMA(ethoxyethylmethacrylate), monomer MAA (methacrylic acid). Optionallyincluded are at least one of the following: crosslinker EGDMA (ethyleneglycoldimethacrylate), initiator Vazo 64 (azobisiloburyronitrile),solvent isopropyl alcohol, inhibitor MEHQ (methyletherhydroquinone) anddiluent glycerine. All components are at appropriate concentrations fortheir intended purpose.

Optionally, a printing device can include a mixture as described abovewithout an ink that can be dispensed along with at least one ink in aseparate container such that the ink and monomer and other optionalcomponents are mixed and dispensed onto a polymer. In either instance,the monomer in the dispensed fluid can be polymerized, thus immobilizingthe ink therein at a defined locus.

Preferably, during printing, a printing device, such as an ink jetprinter, will dispense four different main colors (Black, Magenta, Cyanand Yellow) as discrete dots that correspond to one or more dispensationvolumes of the printing device that do not mix. The dots are depositedas any combination of the main colors to form a collage of discrete dotsof different main colors that, to the unaided human eye generally appearto be a color or pattern rather than a collage of discrete dots. Thus,what is formed is a matrix of individual color dots next to each otherwith a boundary between them.

Such a pattern under magnification may appear as:

Depending on the number of dots, their density and distribution theunaided human eye would perceive different colors, intensity, hue andbrightness.

The ink used in available technology, such as pad transfer printing andpad transfer devices, is highly viscous, such as up to 40,000 cps and ispartially polymerized. Such inks do not run and forms a large discretedot on dispensation. Such printing results in a very unnaturalappearance due to the large, unmixed dots. In the present technology,the viscosity of the ink can be low, such as less than about 100 cps,and can be between about 1 cps and about 10cps. This low viscosityallows the dots to blend, either on their own, or upon the exertion ofexternal forces, such as vibrational energy. In this instance, the dotsdo not remain discrete, but rather blend together, such as:

The result being an image that is a color and pattern that is a“non-dot” color matrix that has a highly realistic appearance to theunaided human eye.

The printing device dispenses ink or mixtures of inks onto a polymer,such as a lens, that corresponds to the digitally encoded image. Morethan one digitally encoded image can be dispensed onto a polymer.Monomer in at least one ink can be appropriately polymerized such thatthe ink is immobilized on or within the polymer. This process can berepeated with the same or different digitally encoded image in the sameor different orientation.

In the alternative, the digitally encoded image can be printed on a padtransfer printing device where it is optionally polymerized. The printedimage can then be transferred to a polymer, such as a contact lens,using appropriate pad transfer printing devices such as they are knownin the art FIG. 4.

III Method of Making a Lens with a Digitally Encoded Image-II

The present invention includes a method of making an article ofmanufacture that includes a digitally encoded image and a polymer,including the steps of printing a digitally encoded image on acomposition comprising a polymer, and forming a lens from said polymer.

In this aspect of the present invention, the digitally encoded image isprinted on a polymer that does not form a lens using a printing device.The polymer with the digitally encoded image is then formed into a lensusing an appropriate method, such as, for example, fabrication,cast-molding, spin-casting or a combination thereof.

When the lens is made using fabrication, the polymer with the digitallyencoded image is formed into a lens using appropriate fabricationmethods, including, for example, stamping, grinding or trimming (see theFIG. 5). The lens can also be made using cast-molding and spin casting(see, for example, FIG. 6, FIG. 7A and FIG. 7B).

FIG. 7B depicts one preferred aspect of the present invention. A lensstructure is made using, for example, spin casting. Etching, burning orcutting processes, such as methods using chemical, mechanical or lasermethods, are used to create well(s) or indentations. These wells orindentations preferably are aligned at a locus that correspond to theiris of an eye. A digitally encoded image is printed on the lens,preferably at the location of the wells or indentations. The ink canoptionally be polymerized or partially polymerized when monomers arepresent in the ink. A layer of polymer is then created on top of thisstructure to form a lens structure. Any appropriate polymerization ofthe structure thus formed or portions thereof can be accomplished usingappropriate methods.

In one instance, a digitally encoded image can be printed onto thesurface of a spin casting device, where the printed digitally encodedimage can be optionally polymerized or partially polymerized. A solutionincluding at least one monomer that can be polymerized to form a lens,such as a contact lens, can be dispensed on the printed digitallyencoded image and spin cast to form a lens. Preferably, the ink(s) usedto print the digitally encoded image include the same monomer(s) used tomake the lens, but that need not be the case. Preferably, the printeddigitally encoded image is non-polymerized or partially polymerized andcontacted with the solution including at least one monomer (preferablythe same monomer used in the ink(s)). The lens is formed byspin-casting, and the polymerization process completed. In that way, aself-adhesion bond or a polymer-polymer bond between the printeddigitally encoded image and the lens is made.

In another instance, a first solution including at least one monomer canbe polymerized or partially polymerized to form a lens, such as acontact lens, in a spin cast device. A digitally encoded image can beprinted on the exposed surface of the lens using a printing device andthe printed digitally encoded image optionally polymerized. A secondsolution including at least one monomer that can be polymerized to forma lens, such as a contact lens, is placed on top of the printeddigitally encoded image and is spin cast to form a lens. The secondsolution preferably is the same solution as the first solution.Preferably, the first solution is partially polymerized prior to theprinting of the digitally encoded image, wherein the printed digitallyencoded image includes the monomer of the first solution. This structureis optionally polymerized or partially polymerized. The second solutionpreferably includes the monomer of the first solution and the ink(s)used to make the digitally encoded image. Preferably, the firstsolution, the printed digitally encoded image and the second solutionform a partially polymerized structure, and the polymerization is thencompleted. In that way a polymer-polymer bond form between thepolymerized first solution and the polymerized printed digitally encodedimage or between the polymerized printed digitally encoded image and thepolymerized second solution. Preferably, such polymer-polymer bond formsbetween the polymerized first solution, the polymerized printeddigitally encoded image and the polymerized second solution.

In another instance, the present invention includes a polymeric surfacethat includes indentation structures, such as but not limited to groovesor wells that can be formed in the polymeric surface by a variety ofmethods, including casting and etching, cutting, drilling or burning,such as by laser etching, physical etching or chemical etching (see, forexample, FIG. 8A and FIG. 8B). Preferably, the indentation structuresare made using appropriate laser etching technologies, such as thosemade by Lumonics Inc.

The indentation structures can be provided at any locus at anyappropriate density of indentation structures on a surface, but arepreferably located in areas where pigmentation or printing is targeted,such as where a desired cosmetic effect is desired for contact lenses.Locations where printing is not desired or desirable can be providedsubstantially without such indentation structures such that printing canbe particularly directed or not directed to chosen locations.

The indentation structures can be of different sizes and shapes, but arepreferably relatively small such that one, a few or many droplets of inkcan be deposited into such indentation structures using appropriateprinting methods or devices (see, for example, FIG. 9). Preferably, oneor a few of the same color or different colors can be deposited in theindentation structures. In one aspect of the present invention, theindentation structures are partially filled or fully filled with inkduring printing processes. If the indentation structures areover-filled, then steps can be taken to remove excess ink, such as, forexample, blotting, scraping or machining, such as polishing, buffing orgrinding.

In a particularly preferred aspect of the present invention, the inkincludes at least one polymerizable monomer that can be polymerizedafter dispensation. If the indentation structures are not filled withsuch ink, then additional material, such as monomer with or without inkcan be dispensed onto the polymer. As in other aspects of the presentinvention, the skilled artisan has the choice of when and how the ink ormonomer can be polymerized. For example, in one preferred aspect of thepresent invention, the ink is dispensed into indentation structures suchthat the indentation structures are not filled. The ink is thenoptionally polymerized, and additional monomer is dispensed on thepolymer to fill or overfill the indentation structures. The monomer isthen polymerized, and the polymer is ready for final processing, if any.

Preferably, the indentation structures facilitate holding the dispensedink in a location such that a digitally encoded image is localized andheld in place. This aspect of the present invention is most appropriatefor inks that are of relatively low viscosity such that the ink does notrun due to the curvatures of printed surfaces, such as are present inlenses.

In one preferred aspect of the present invention, droplets of ink thatinclude a monomer are deposited on a surface, such as a polymer, thatincludes indentation structures. One or more droplets of the same ordifferent color are deposited in such indentation structures such thatdifferent combinations of colors, chroma, intensity and hues can belocalized in one or more indentation structures.

In another aspect of the present invention, a lens such as anon-hydrated lens or hydrated lens, such as a partially hydrated orfully hydrated lens, can be mounted, preferably centered, and masked ona fixture (see, for example FIG. 10). When hydrated, water on or in thelens can optionally be removed, such as by blotting. A hydrated lens canoptionally then be dehydrated, such as to partial or substantialdehydration, by appropriate methods such as by air, heat orcentrifugation. The lens can be printed or tinted using appropriatemethods such as those described herein. Preferably but optionally, thelens includes indentation structures such as those described herein.This process and device allow for the automation of printing processesand manufacture processes described herein.

The present invention also includes a method of making an article ofmanufacture that includes a digitally encoded image and a polymer,including the steps of printing a digitally encoded image on acomposition comprising at least one monomer, polymerizing said at leastone monomer to form at least one polymer, and forming a lens from saidat least one polymer.

The present invention includes a method of making an article ofmanufacture that includes a digitally encoded image and a polymer,including the steps of printing an image on at least one first surface,transferring said image to at least one second surface comprising amonomer or a polymer, and forming a lens from said second surface.

IV Digital Images

The present invention includes an article of manufacture, including: atleast one information storage medium, and at least one digital image,wherein the at least one digital image comprises at least a portion ofan image, such as, but not limited to, the iris of an eye. Theinformation storage medium can be any appropriate electronic storagemedium and is preferably in a machine readable format and preferablyassociated with a central processing unit. A plurality of digital imagescan be stored in a database.

The invention is drawn not only to digitally encoded images, but also tothe digitally encoded images when provided in a format, such as data,such as data in a patentable format. Thus, for example, the presentinvention encompasses a format such as a machine-readable formatcomprising data such as one or more digitally encoded images of interestas determined or isolated according to the present invention.

For example, the invention includes data in any format, preferablyprovided in a medium of expression such as printed medium, perforatedmedium, magnetic medium, holographs, plastics, polymers or copolymerssuch as cyclolifin polymers. Such data can be provided on or in themedium of expression as an independent article of manufacture, such as adisk, tape or memory chip, or be provided as part of a machine, such asa computer, that is either processing or not processing the data, suchas part of memory or part of a program. The data can also be provided asat least a part of a database. Such database can be provided in anyformat, leaving the choice or selection of the particular format,language, code, selection of data, form of data or arrangement of datato the skilled artisan. Such data is useful, for example, for comparingsequences obtained by the present invention with known sequences toidentify novel sequences.

One aspect of the invention is a data processing system for storing andselecting at least a portion of data provided by the present invention.The data processing system is useful for a variety of purposes, forexample, for storing, sorting or arranging such data in, for example,database format, and for selecting such data based on a variety ofcriteria, such as colors, patterns, sources and the like. Such a dataprocessing system can include two or more of the following elements inany combination:

I. A computer processing system, such as a central processing unit(CPU). A storage medium or means for storing data, including at least aportion of the data of the present invention or at least a portion ofcompared data, such as a medium of expression, such as a magnetic mediumor polymeric medium;

II. A processing program or means for sorting or arranging data,including at least a portion of the data of the present invention,preferably in a database format, such as a database program or anappropriate portion thereof such as they are known in the art (forexample EXCEL or QUATROPRO);

III. A processing program or means for comparing data, including atleast a portion of the data of the present invention, which can resultin compared data, such as digital image comparing programs or anappropriate portion thereof;

IV. A processing program or means for analyzing at least a portion ofthe data of the present invention, compared data, or a portion thereof,particularly statistical analysis, such as programs for analyzingdigitally encoded images using statistical analysis programs or imagecomparing programs or an appropriate portion thereof as they are knownin the art;

V. A formatting processing program or means that can format an outputfrom the data processing system, such as data of the present inventionor a portion thereof or compared data or a portion thereof, such asdatabase management programs or word-processing programs, or appropriateportions thereof as they are known in the art; or

VI. An output program or means to output data, such as data of thepresent invention or a portion thereof or compared data or a portionthereof in a format useful to an end user, such as a human or anotherdata processing system, such as database management programs orword-processing programs or appropriate portions thereof as they areknown in the art. Such formats useful to an end user can be anyappropriate format in any appropriate form, such as in an appropriatelanguage or code in an appropriate medium of expression.

V Systems

The present invention also includes a system, including: an article ofmanufacture of the present invention and a printing device. The articleof manufacture includes at least one digitally encoded image, preferablyin the form of a database within a central processing unit. The centralprocessing unit preferably is linked to a printing device that includesappropriate software and hardware to direct the printing device to printa digitally encoded image, such as during the operation of a method ofthe present invention. The system can include additional components,such as devices for the manufacture of lens structures of the presentinvention. For example, the system of the present invention can includea lens manufacturing device, such as a spin casting device or a padtransfer device. Preferably, the central processing unit includeshardware and software that allows the central processing unit to directthe manufacture of a lens using at least one method of the presentinvention.

As a preferred embodiment of the present invention, a system of thepresent invention includes a first central processing unit thatoptionally includes an article of manufacture of the present invention,wherein the article of manufacture of the present invention can belocated on at least one second central processing unit separate indistance from the first central processing unit and is linked to theremainder of the system. The system preferably includes a printingdevice as described herein or known in the art that is capable ofprinting at least one digital image of the present invention. The systempreferably includes a lens manufacturing device, such as a spin-castdevice or a pad transfer device. In that regard, the system of thepresent invention includes dispensation and other hardware, software andreagents used to practice a method of the present invention. Preferably,the system is automated such that a user can select a digital image andthe first central processing unit directs and coordinates themanufacture of at least one lens by the remainder of the elements of thesystem, such as the printing device and a lens manufacture device.

VI Compositions of Matter Including Ink

The present invention also includes a composition of matter, includingat least one ink, dye, vat dye, particle, pigment, reactive dye or diazodye. The composition of matter also includes at least one of a binder,monomer, polymer, homopolymer, heteropolymer, copolymer, and initiator,UV initiator, thermal initiator, solvent, dispersant, anti-bacterialagent, anti-microbial agent, anti-fungal agent, disinfectant, thickener,humectant, non-kogating agent, anti-corrosion agent, antiseptic agent ornon-oxidizing agent. The indicated agents can be provided in anycombination and at concentrations or amounts appropriate for theindicated function.

The compositions of matter of the present invention do not include theinks set forth in U.S. Pat. No. 4,303,9214 to Young, issued Dec. 1,1981. In particular, the composition of matter of the present inventionare preferably water resistant after polymerization such that pigmentsin the ink substantially stay where they have been deposited by printingprocesses. In addition, the compositions of matter of the presentinvention are preferably swellable after polymerization, particularly insolvents, preferably water. In addition, the inks of the presentinvention, are preferably capable of chemically bonding, cross-linkingor otherwise binding with polymers or monomers on the surface beingprinted. For example, the ink of the present invention can includemonomers that can be polymerized with a polymer or monomer on thesurface being printed.

The composition of the present invention can be provided in a printingdevice, such as an ink jet printing device, a piezo printing device, athermal printing device, a laser printing device or a pad transferprinting device.

VII Method of Doing Business

The present invention also includes a method of doing business,including the steps of: obtaining a digital image from a person,database (such as a database of the present invention) or image andprinting said digital image to make at least one lens or a pair oflenses that includes the printed digital image. Preferably, the lens orlenses are made using a method of the present invention. Furthermore,the lens or lenses are preferably made using a system of the presentinvention.

In this aspect of the present invention, a customer selects an imagethat she would like as part of a lens. The image can be any image, suchas a fanciful image or any type, such as novelty images including swirlsand the like, or an image that is a high quality image of an iris, suchas from a human or animal. The image can be selected from a database,such as a database of digital images. Alternatively, the customer canidentify and select an image from a variety of sources, such as acollection of photographs of people or animals. Such collections can bein an appropriate storage medium, such as an electronic database or acollection or compilation of photographs or pictures. Alternatively, thecustomer can provide a selected image for use in the present method. Aselected non-digital image can be transformed into a digital image usingappropriate scanning technologies as they are known in the art. Suchscanned images can become part of a database of the present invention.The selection process can take place at virtually any location, such asat a vendor's or manufacture's physical location or via computer, suchas via the Internet.

The digital image selected by the customer can then be conveyed to thevendor's or manufacture's physical location via an appropriate method,such as through personal communication, phone communication,communication through printed materials such as order forms through themail, or through electronic media, such as through the Internet. Aselected image can be analyzed using appropriate software, such as imageanalysis and comparing software, for patterns, hue, chroma andintensity. The image can then be transformed into a signal for use by aprinting device such that the image is reproduced as to colors andpatterns by the printing device. The vendor notifies the manufacture ofthe order and provides the manufacture with the necessary information,such as the digital image. The vendor and manufacturer can be the sameor different person, company or entity and can be at the same ordifferent physical location. The manufacturer then manufacture's thelens or lenses and delivers the manufactured lens or lenses to thevendor or customer by an acceptable method such as check, cash, creditor credit card. The vendor or manufacturer receive payment asappropriate

The digital image can be printed by a printing device following a methodof the present invention or other method known in the art or laterdeveloped that results in the production of a lens, particularly acontact lens, of the present invention. Preferably, a printing devicethat utilizes at least two colors, at least three colors or at leastfour colors is used. This aspect of the present invention preferablyutilizes a system of the present invention.

EXAMPLES Example 1 Preparation of Inks

This example provides ink compositions used to make lenses that includea digitally encoded image. Four ink preparations are preferred for usein printing devices, although more or less can be used.

The ink preparations include a base ink formulation that include thefollowing: monomer (HEMA), initiator (BME), crosslinker (EGDMA), pigment#1, diluent (glycerine), solvent (isopropanol), optional pigment #2(titanium oxide), dispersant (polyvinyl alcohol), humectant (ehtyleneglycol), co-monomer (methacrylic acid), inhibitor (MEHQ), antikogatingagent (methyl propanediol), and antioxident (alkylated hydroquinone).The concentration of these constituents are as appropriate for making alens of desired characteristics and physical properties. Pigment #1 canbe any ink or combination of inks to provide a desired color. Thepreferred colors for four ink formulations are A1: Black; A2: Magenta,A3: Yellow and A4: Cyan. Appropriate inks for A1, A2, A3, and A4 aredescribed in U.S. Pat. Nos. 5,176,745, 4,889,520, 5,658,376, 4,793,264,5,389,132, 5,271,765, 5,062,892 and U.S. Pat. No. 5,372,852.

A preferred monomer mixture for making clear lenses is designate A5, andhas the following formulation: monomer (HEMA), monomer (EOEMA), monomer(MAA), crosslinker (EGDMA), initiator (Vazo-64), inhibitor (MEHQ) anddiluent (glycerine). The concentration of these constituents are asappropriate for making a lens of desired characteristics and physicalproperties.

When inks are used in jet printing devices, the ink is preferably waterbased or monomer based (U.S. Pat. No. 5,658,376). The ink is preferablysoluble in water and an organic solvent and preferably includes adisperse dye or pigment. A water soluble polymer such as polyvinylalcohol and a dispersant such as polyvinyl pyrolidone are preferred. Asurfactant is preferably provided, such as polyoxyethylene alkyl etheror polyoxyethylene alkylpheyl ether having an aminic acid group. The inkpreferably includes a surfactant, such as between about 0.3% and about1% by weight. The ink preferably includes an antiseptic agent such asProxel (Zeneca, U.K.). The ink preferably has a pH of between about 7and about 10 and a viscosity at about 25° C. of between about 2 mPas andabout 6 mPas. Antioxidants, such as low corrosion or antioxidant agents,such as alkylated hydroquinone can also be included, preferably betweenabout 0.1% and about 0.5% by weight (U.S. Pat. No. 5,389,132). An inkcan also include a humectant such as 1,3-dioxane-5,5-dimethanol,2-methyl-1,3-propane diol, ethylene glycol or diethylene glycol. Whenused in printing, the driving frequency is preferably between about 3kHz and about 8 kHz (see generally, U.S. Pat. No. 5,658,376). Preferredink properties include a surface tension of between about 20 dynes/cmand about 70 dynes/cm and a viscosity between about 1.0 cp and about 2.0cp (U.S. Pat. No. 5,271,765).

Example 2 Printing Methodologies—Surfaces and Laminates

This example, as depicted in FIG. 1 and FIG. 11, provides a methodologyfor printing digitally encoded images. An image, such as of an iris, isscanned into a digital form using appropriate hardware and software toprovide a digitally encoded image. The digitally encoded image is storedin an appropriate storage medium, such as an electronic medium, such asin a dat0abase. A selected image is sent via an electronic signal to aprinting device, such as an inkjet printing device, a bubble jetprinting device or a laser printing device, through a processing unit.The printing device preferably includes ink formulations A1, A2, A3 andA4 in separate compartments, such as in a printing cassette (FormulationA6), and optionally formulation A5 in a separate compartment or in aseparate cassette. The printing device, under the direction of aprocessing unit, prints the digitally encoded image by mixing anddispensing, or dispensing individually, the inks of formulation A6 ontoa surface, such as a polymerized polymer, a partially polymerizedpolymer or an unpolymerized polymer. After a printing step or other timeduring the manufacture process, the structure can be subjected toenergy, such as vibrational energy, that can smear the printed digitalimage, particularly when in an unpolymerized or partially polymerizedstate, such that the resulting printed digital image has a naturalappearance. This process can be repeated a plurality of times using thesame or different digitally encoded image. The surface can be maintainedin the same orientation or rotated between printing steps. The printeddigitally encoded image can be polymerized or partially polymerizedafter each printing step or after all printing steps are completed.

In the alternative, as depicted in FIG. 12 a digitally encoded image canbe printed on a structure designed to transfer a printed digitallyencoded image to a surface. Such structures known in the art include padtransfer devices. The digitally encoded image can be printed onto thestructure and polymerized or partially polymerized prior to the printeddigitally encoded image being transferred to a surface.

The surface that the digitally encoded surface is printed upon, ortransferred to, can be partially polymerized or fully polymerized, andcan be rough or smooth. Roughened surfaces are obtained by methods knownin the art, such as etching, laser cutting or burning, grinding orcutting. The surfaces can be made by appropriate methods, such as bycast molding, spin casting lathe fabrication or laser fabrication.

Laminate structures that include printed digitally encoded images can bemade by forming a surface with printed digitally encoded image on suchsurface. Additional monomer, such as formulation A5, can be placed onthe printed digitally encoded image and polymerized to form a laminatestructure that includes a first polymer layer (preferably clear), aprinted digitally encoded image, and a second polymer layer (preferablyclear). In making these laminate structures, the first polymer layer canbe partially or fully polymerized prior to printing of the digitallyencoded image. This structure in turn can be partially or fullypolymerized. The monomer for the second polymer layer is then dispensed,and this structure is then partially or fully polymerized (see, forexample, FIG. 2 and FIG. 13).

Example 3 Printing Methods—Within a Well or Indentation on a Surface

This example, as depicted in FIG. 14 provides methods of making lensesthat include a digitally encoded image, wherein the digitally encodedimage is provided in a well structure(s) or an indentation(s). In thisaspect of the present invention, a structure including a surface offully polymerized or partially polymerized polymer is provided. A wellor indentiation is created on the structure that corresponds at least inpart to the size and shape of the digitally encoded image to be printed.The well can be larger in size or of a different shape than thedigitally encoded image to be printed. The methods descried in Example 2are used to print the digitally encoded image on the surface of thewell. A laminate structure within the well can also be made followingthe methods described in Example 2.

Example 4 Finishing of Lenses

The structure resulting for these methods can be finished usingsecondary operations known in the art as they are needed, such as, forexample, cutting, grinding, edging, polishing or the like to form a lensof desired optical, cosmetic or functional quality or characteristics.For soft contact lenses, the dry lenses may be hydrated usingconventional methods to form a finished product. The finished lenses canbe packaged in any appropriate packaging as they are known in the art,such as vials, tubes, blisters or other structures. The packaging caninclude appropriate solutions and instructions for use or description ofthe product and its care.

All publications, including patent documents and scientific articles,referred to in this application and the bibliography and attachments areincorporated by reference in their entirety for all purposes to the sameextent as if each individual publication were individually incorporatedby reference.

All headings are for the convenience of the reader and should not beused to limit the meaning of the text that follows the heading, unlessso specified.

What is claimed is:
 1. A method of making a lens comprising a digitallyencoded image and a polymer, comprising: a) providing a polymer; b)providing an ink; c) providing directly to said polymer a digitallyencoded image made with said ink; wherein at least a portion of saiddigitally encoded image is produced using ink jet printing; furtherwherein said ink jet printing comprises piezo printing.
 2. The method ofclaim 1, wherein said digitally encoded image comprises a single colorimage.
 3. The method of claim 1, wherein said digitally encoded imagecomprises a multi-colored image.
 4. The method of claim 1, wherein saiddigitally encoded image is transparent.
 5. The method of claim 1,wherein said digitally encoded image is opaque.
 6. The method of claim1, wherein said digitally encoded image is partially opaque.
 7. Themethod of claim 1, wherein said polymer comprises a hydrogel.
 8. Themethod of claim 1, wherein said lens is a soft lens.
 9. The method ofclaim 1, wherein said lens is a hard lens.
 10. The method of claim 1,wherein said lens is a hybrid lens.
 11. The method of claim 1, whereinsaid lens comprises between about 0% percent and about 80% percentwater.
 12. The method of claim 1, wherein said lens is permeable tooxygen.
 13. The method of claim 1, wherein said polymer is hydrophobic.14. The method of claim 1, wherein said polymer is hydrophilic.
 15. Themethod of claim 1, wherein said polymer is selected from the groupconsisting of acrylics, silicones and polycarbonates.
 16. The method ofclaim 1, wherein said polymer comprises an acrylic.
 17. The method ofclaim 1, wherein said polymer is an acrylic.
 18. The method of claim 1,wherein said polymer comprises a silicone.
 19. The method of claim 1,wherein said polymer is a silicone.
 20. The method of claim 1, whereinsaid polymer comprises a polycarbonate.
 21. The method of claim 1,wherein said polymer is a polycarbonate.
 22. The method of claim 1,wherein said ink-jet printing further comprises thermal printing. 23.The method of claim 1, wherein a portion of said digitally encoded imageis produced using pad-transfer printing.
 24. The method of claim 1,wherein said digitally encoded image is on at least one surface of saidpolymer.
 25. The method of claim 24, wherein said polymer forms a lens.26. The method of claim 1, wherein said digitally encoded image is onone surface of said polymer.
 27. The method of claim 26, wherein saidpolymer forms a lens.
 28. The method of claim 1, wherein said digitallyencoded image is printed directly on said polymer.
 29. The method ofclaim 28, wherein said polymer forms a lens.
 30. The method of claim 1,wherein said digitally encoded image is printed directly on the surfaceof a mold.
 31. The method of claim 30, wherein said mold is used forform at least one surface of said polymer.
 32. The method of claim 31,wherein said polymer forms a lens.
 33. The method of claim 1, whereinsaid digitally encoded image is within said polymer.
 34. The method ofclaim 33, wherein said polymer forms a lens.
 35. The method of claim 1,wherein said digitally encoded image is laminated within said polymer.36. The method of claim 35, wherein said polymer forms a lens.
 37. Themethod of claim 1, wherein said digitally encoded image is provideddirectly to said polymer.
 38. The method of claim 37, wherein saidpolymer forms a lens.
 39. The method of claim 1, wherein said inkcomprises at least one dye.
 40. The method of claim 1, wherein said inkcomprises at least one vat dye.
 41. The method of claim 1, wherein saidink comprises at least one particle.
 42. The method of claim 1, whereinsaid ink comprises at least one pigment.
 43. The method of claim 1,wherein said ink comprises at least one reactive dye.
 44. The method ofclaim 1, wherein said ink comprises at least one diazo dye.
 45. Themethod of claim 1, wherein said ink comprises water.
 46. The method ofclaim 1, wherein said ink comprises a solvent.
 47. The method of claim1, wherein said ink comprises a monomer.
 48. The method of claim 1,wherein said ink comprises a polymer.
 49. The method of claim 1, whereinsaid ink comprises a homopolymer.
 50. The method of claim 1, whereinsaid ink comprises a heteropolymer.
 51. The method of claim 1, whereinsaid ink comprises a copolymer.
 52. The method of claim 1, wherein saidink comprises an initiator.
 53. The method of claim 52, wherein saidinitiator is a UV initiator.
 54. The method of claim 52, wherein saidinitiator is a thermal initiator.
 55. The method of claim 1, whereinsaid ink comprises a dispersant.
 56. The method of claim 1, wherein saidink comprises an anti-bacterial agent.
 57. The method of claim 1,wherein said ink comprises an anti-fungal agent.
 58. The method of claim1, wherein said ink comprises a disinfectant.
 59. The method of claim 1,wherein said ink comprises a humectant.
 60. The method of claim 1,wherein said digitally encoded image is entrapped within said polymer.61. The method of claim 1, wherein said digitally encoded image forms achemical bond with said polymer.
 62. The method of claim 1, wherein saiddigitally encoded image forms a self-adhesion bond with said polymer.63. The method of claim 1, wherein said digitally encoded image forms apolymer-polymer bond with said polymer.
 64. The method of claim 1,wherein said digitally encoded image comprises at least one pattern. 65.The method of claim 1, wherein said digitally encoded image comprises atleast one color.
 66. The method of claim 1, wherein said digitallyencoded image comprises an image of an iris of an eye.
 67. The method ofclaim 1, wherein said digitally encoded image is derived from at leastone color.
 68. The method of claim 1, wherein said digitally encodedimage is derived from at least two separate colors.
 69. The method ofclaim 1, wherein said digitally encoded image is derived from a mixtureof at least two separate colors.
 70. The method of claim 1, wherein saiddigitally encoded image is derived from at least three separate colors.71. The method of claim 1, wherein said digitally encoded image isderived from a mixture of at least three separate colors.
 72. The methodof claim 1, wherein said digitally encoded image is derived from atleast four separate colors.
 73. The method of claim 1, wherein saiddigitally encoded image is derived from a mixture of at least fourseparate colors.
 74. A method of making a lens comprising a digitallyencoded image and a polymer, comprising: a) providing a polymer; b)providing an ink; c) providing directly to said polymer a digitallyencoded image made with said ink; wherein at least a portion of saiddigitally encoded image is produced using ink jet printing; furtherwherein said ink jet printing comprises thermal printing.
 75. The methodof claim 74, wherein said digitally encoded image comprises a singlecolor image.
 76. The method of claim 74, wherein said digitally encodedimage comprises a multi-colored image.
 77. The method of claim 74,wherein said digitally encoded image is transparent.
 78. The method ofclaim 74, wherein said digitally encoded image is opaque.
 79. The methodof claim 74, wherein said digitally encoded image is partially opaque.80. The method of claim 74, wherein said polymer comprises a hydrogel.81. The method of claim 74, wherein said lens is a soft lens.
 82. Themethod of claim 74, wherein said lens is a hard lens.
 83. The method ofclaim 74, wherein said lens is a hybrid lens.
 84. The method of claim74, wherein said lens comprises between about 0% percent and about 80%percent water.
 85. The method of claim 74, wherein said lens ispermeable to oxygen.
 86. The method of claim 74, wherein said polymer ishydrophobic.
 87. The method of claim 74, wherein said polymer ishydrophilic.
 88. The method of claim 74, wherein said polymer isselected from the group consisting of acrylics, silicones andpolycarbonates.
 89. The method of claim 74, wherein said polymercomprises an acrylic.
 90. The method of claim 74, wherein said polymeris an acrylic.
 91. The method of claim 74, wherein said polymercomprises a silicone.
 92. The method of claim 74, wherein said polymeris a silicone.
 93. The method of claim 74, wherein said polymercomprises a polycarbonate.
 94. The method of claim 74, wherein saidpolymer is a polycarbonate.
 95. The method of claim 74, wherein aportion of said digitally encoded image is produced using pad-transferprinting.
 96. The method of claim 74, wherein said digitally encodedimage is on at least one surface of said polymer.
 97. The method ofclaim 96, wherein said polymer forms a lens.
 98. The method of claim 74,wherein said digitally encoded image is on one surface of said polymer.99. The method of claim 98, wherein said polymer forms a lens.
 100. Themethod of claim 74, wherein said digitally encoded image is printeddirectly on said polymer.
 101. The method of claim 100, wherein saidpolymer forms a lens.
 102. The method of claim 74, wherein saiddigitally encoded image is printed directly on the surface of a mold.103. The method of claim 102, wherein said mold is used for form atleast one surface of said polymer.
 104. The method of claim 103, whereinsaid polymer forms a lens.
 105. The method of claim 74, wherein saiddigitally encoded image is within said polymer.
 106. The method of claim105, wherein said polymer forms a lens.
 107. The method of claim 74,wherein said digitally encoded image is laminated within said polymer.108. The method of claim 107, wherein said polymer forms a lens. 109.The method of claim 74, wherein said digitally encoded image is provideddirectly to said polymer.
 110. The method of claim 109, wherein saidpolymer forms a lens.
 111. The method of claim 74, wherein said inkcomprises at least one dye.
 112. The method of claim 74, wherein saidink comprises at least one vat dye.
 113. The method of claim 74, whereinsaid ink comprises at least one particle.
 114. The method of claim 74,wherein said ink comprises at least one pigment.
 115. The method ofclaim 74, wherein said ink comprises at least one reactive dye.
 116. Themethod of claim 74, wherein said ink comprises at least one diazo dye.117. The method of claim 74, wherein said ink comprises water.
 118. Themethod of claim 74, wherein said ink comprises a solvent.
 119. Themethod of claim 74, wherein said ink comprises a monomer.
 120. Themethod of claim 74, wherein said ink comprises a polymer.
 121. Themethod of claim 74, wherein said ink comprises a homopolymer.
 122. Themethod of claim 74, wherein said ink comprises a heteropolymer.
 123. Themethod of claim 74, wherein said ink comprises a copolymer.
 124. Themethod of claim 74, wherein said ink comprises an initiator.
 125. Themethod of claim 124, wherein said initiator is a UV initiator.
 126. Themethod of claim 124, wherein said initiator is a thermal initiator. 127.The method of claim 74, wherein said ink comprises a dispersant. 128.The method of claim 74, wherein said ink comprises an anti-bacterialagent.
 129. The method of claim 74, wherein said ink comprises ananti-fungal agent.
 130. The method of claim 74, wherein said inkcomprises a disinfectant.
 131. The method of claim 74, wherein said inkcomprises a humectant.
 132. The method of claim 74, wherein saiddigitally encoded image is entrapped within said polymer.
 133. Themethod of claim 74, wherein said digitally encoded image forms achemical bond with said polymer.
 134. The method of claim 74, whereinsaid digitally encoded image forms a self-adhesion bond with saidpolymer.
 135. The method of claim 74, wherein said digitally encodedimage forms a polymer-polymer bond with said polymer.
 136. The method ofclaim 74, wherein said digitally encoded image comprises at least onepattern.
 137. The method of claim 74, wherein said digitally encodedimage comprises at least one color.
 138. The method of claim 74, whereinsaid digitally encoded image comprises an image of an iris of an eye.139. The method of claim 74, wherein said digitally encoded image isderived from at least one color.
 140. The method of claim 74, whereinsaid digitally encoded image is derived from at least two separatecolors.
 141. The method of claim 74, wherein said digitally encodedimage is derived from a mixture of at least two separate colors. 142.The method of claim 74, wherein said digitally encoded image is derivedfrom at least three separate colors.
 143. The method of claim 74,wherein said digitally encoded image is derived from a mixture of atleast three separate colors.
 144. The method of claim 74, wherein saiddigitally encoded image is derived from at least four separate colors.145. The method of claim 74, wherein said digitally encoded image isderived from a mixture of at least four separate colors.
 146. A methodof making a lens comprising a digitally encoded image and a polymer,comprising: a) providing a polymer; b) providing an ink; c) providingdirectly to said polymer a digitally encoded image made with said ink;wherein at least a portion of said digitally encoded image is producedusing ink jet printing; further wherein said ink jet printing comprisespiezo printing; further wherein said ink comprises a colorant.
 147. Themethod of claim 146, wherein said ink comprises a monomer.
 148. Themethod of claim 147, wherein said monomer comprises a hydrophilicmonomer.
 149. The method of claim 148, wherein said hydrophilic monomercomprises a methacrylate monomer.
 150. The method of claim 146, whereinsaid ink comprises a dispersing agent.
 151. The method of claim 146,wherein said ink comprises an initiator.
 152. The method of claim 151,wherein said ink comprises a UV initiator.
 153. The method of claim 151,wherein said ink comprises a thermal initiator.
 154. The method of claim146, wherein said lens comprises acrylic polymer.
 155. The method ofclaim 146, wherein said colorant comprises a pigment.
 156. The method ofclaim 146, wherein said colorant comprises a dye.
 157. The method ofclaim 156, wherein said dye comprises a reactive dye.
 158. The method ofclaim 146, wherein said ink comprises a solvent.
 159. The method ofclaim 146, wherein said ink comprises an antibacterial agent.
 160. Themethod of claim 146, wherein said ink comprises an antikogating agent.161. The method of claim 146, wherein said ink comprises a humectant.162. The method of claim 146, wherein said ink comprises a surfactant.163. The method of claim 146, wherein said ink comprises a thickener.164. The method of claim 146, wherein said ink comprises a bondingagent.
 165. The method of claim 146, wherein said ink has a viscositybetween about 1 centipoise and about 200 centipoise.
 166. The method ofclaim 146, wherein said ink has a surface tension between about 20dynes/cm and about 70 dynes/cm.
 167. The method of claim 146, furtherwherein said ink-jet printing uses thermal printing.
 168. A method ofmaking a lens comprising a digitally encoded image and a polymer,comprising: a) providing a polymer; b) providing an ink; c) providingdirectly to said polymer a digitally encoded image made with said ink;wherein at least a portion of said digitally encoded image is producedusing ink jet printing; further wherein said ink jet printing comprisesthermal printing; further wherein said ink comprises a colorant. 169.The method of claim 168, wherein said ink comprises a monomer.
 170. Themethod of claim 169, wherein said monomer comprises a hydrophilicmonomer.
 171. The method of claim 170, wherein said hydrophilic monomercomprises a methacrylate monomer.
 172. The method of claim 168, whereinsaid ink comprises a dispersing agent.
 173. The method of claim 168,wherein said ink comprises an initiator.
 174. The method of claim 173,wherein said ink comprises a UV initiator.
 175. The method of claim 173,wherein said ink comprises a thermal initiator.
 176. The method of claim168, wherein said lens comprises acrylic polymer.
 177. The method ofclaim 168, wherein said colorant comprises a pigment.
 178. The method ofclaim 168, wherein said colorant comprises a dye.
 179. The method ofclaim 168, wherein said dye comprises a reactive dye.
 180. The method ofclaim 168, wherein said ink comprises a solvent.
 181. The method ofclaim 168, wherein said ink comprises an antibacterial agent.
 182. Themethod of claim 168, wherein said ink comprises an antikogating agent.183. The method of claim 168, wherein said ink comprises a humectant.184. The method of claim 168, wherein said ink comprises a surfactant.185. The method of claim 168, wherein said ink comprises a thickener.186. The method of claim 168, wherein said ink comprises a bondingagent.
 187. The method of claim 168, wherein said ink has a viscositybetween about 1 centipoise and about 200 centipoise.
 188. The method ofclaim 168, wherein said ink has a surface tension between about 20dynes/cm and about 70 dynes/cm.